ReHabGame: a game-based rehabilitation system for motor-impaired individuals
| ISRCTN | ISRCTN10134617 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10134617 |
| IRAS number | 356908 |
| Secondary identifying numbers | ETH2425-3331 |
- Submission date
- 06/05/2025
- Registration date
- 19/05/2025
- Last edited
- 11/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
ReHabGame is a research study exploring a fun and interactive way to support people who have difficulty moving their arm or hand due to a neurological condition like a stroke, brain injury, or multiple sclerosis. These conditions can make everyday tasks like eating, dressing, or writing more difficult, and traditional rehabilitation exercises can sometimes feel repetitive or boring. ReHabGame aims to make therapy more engaging by turning it into a game with rewards. Using a depth camera (Kinect), the system tracks the person’s movements without needing any wearable sensors. The player moves their arm or hand to control a virtual avatar on the screen, completing tasks like reaching, grasping, or pressing buttons. The game provides instant feedback and adapts to the person’s abilities, helping them improve.
Who can participate?
Adult patients (aged 18 years or older) diagnosed with a neurological condition, such as stroke, traumatic brain injury (TBI), or multiple sclerosis (MS), that affects upper-limb motor function.
What does the study involve?
In this study, participants will be invited to use ReHabGame for 6 to 8 weeks, attending two short sessions (each 30 min) per week. Their arm movement will be assessed before and after the program using a standard test, and again around 6 months later to see if any improvements last. The follow-up can be in-person or online over Microsoft Teams. They will also be asked how easy and enjoyable the game was and whether they would recommend it to others.
This is a feasibility study, meaning its aim is to determine whether the game works well enough for real rehabilitation settings, how easy it is to participate in the study, and whether people like using it. The information gathered will help to design a larger study in the future.
What are the possible benefits and risks of participating?
ReHabGame has the potential to offer a motivating, low-cost, and home-friendly option for people working to regain their independence after neurological injury.
Where is the study run from?
Anglia Ruskin University (UK)
When is the study starting and how long is it expected to run for?
July 2024 to July 2027
Who is funding the study?
Anglia Ruskin University (UK)
Who is the main contact?
Dr Shabnam Sadeghi Esfahlani, shabnam.sadeghi-esfahlani@aru.ac.uk
Contact information
Scientific, Principal Investigator
Anglia Ruskin University
Bishop Hall Lane
Chelmsford
CM1 1SQ
United Kingdom
 ORCID ID |
0000-0002-1443-0330 |
|---|---|
| Phone | +44 (0)7944281517 |
| shabnam.sadeghi-esfahlani@aru.ac.uk |
Public
Bishop Hall Lane
Danbury
Chelmsford
CM1 1SQ
United Kingdom
| Phone | +44 (0)7912 932859 |
|---|---|
| hassan.shirvani@aru.ac.uk |
Study information
| Study design | Pilot randomized controlled feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Other therapist office |
| Study type | Efficacy |
| Participant information sheet | 47290_PIS.pdf |
| Scientific title | ReHabGame: a feasibility randomised controlled study of a markerless, Kinect-based game intervention versus standard physiotherapy to improve upper limb motor function in adults with neurological impairments |
| Study acronym | ReHabGame |
| Study objectives | Primary Hypothesis (Feasibility): ReHabGame is a feasible and acceptable rehabilitation tool, demonstrated by participant retention, adherence, usability scores, and absence of serious adverse events. Secondary Hypothesis (Exploratory Clinical): Participants using ReHabGame will show greater improvements in upper-limb motor function (FMA-UE score) compared to those receiving standard rehabilitation. |
| Ethics approval(s) |
Submitted 11/06/2025, East of England - Essex Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8177; essex.rec@hra.nhs.uk), ref: Reference number not provided |
| Health condition(s) or problem(s) studied | Neurological Condition: Diagnosed with stroke, traumatic brain injury (TBI), or multiple sclerosis (MS) that impacts upper-limb motor function. |
| Intervention | ReHabGame is a non-invasive, game-based digital therapeutic intervention designed to support upper-limb rehabilitation in individuals with neurological impairments (e.g., stroke, TBI, MS). It combines physiotherapy principles with interactive gaming, using a markerless motion-tracking system (Microsoft Kinect) to deliver repetitive, goal-directed arm and hand exercises within a virtual environment. The system provides: 1. Real-time visual feedback 2. Adaptive task difficulty based on performance 3. Performance logging (range of motion, task completion, frequency) This is a two-arm, randomised, interventional feasibility study assessing the use of ReHabGame, a game-based rehabilitation system using Kinect motion tracking, for adults with upper-limb motor impairments due to neurological conditions. Intervention Group: Participants in the intervention arm will engage with ReHabGame for 6–8 weeks, completing 1–2 sessions per week, each lasting approximately 30 minutes. The intervention will be administered in a clinical or supervised setting. ReHabGame uses a Microsoft Kinect sensor to deliver goal-oriented upper-limb motor tasks within an interactive, adaptive virtual environment. The system captures movement metrics and provides real-time visual feedback to support rehabilitation. Control Group: According to their usual treatment pathway, participants in the control group will receive standard rehabilitation care (e.g., physiotherapy) or no additional intervention. Details of the control condition will be recorded for each participant. Outcome assessments (e.g., Fugl-Meyer Assessment for upper-limb function) will be conducted at baseline, post-intervention (week 6–8), and at a follow-up appointment approximately 6 months later. Additional feasibility metrics, system usage data, and participant experience questionnaires will be collected. Descriptive statistics for feasibility metrics: Paired t-tests or Wilcoxon signed-rank tests for within-group changes Independent t-tests or Mann–Whitney U tests for between-group comparisons Cohen’s d for effect size estimation Thematic analysis for qualitative feedback using NVivo or MAXQDA |
| Intervention type | Behavioural |
| Primary outcome measure | Both quantitative (e.g., clinical assessments) and qualitative (e.g., questionnaire) methods will be employed to provide a comprehensive understanding of ReHabGame’s effectiveness and user experience: 1. Quantitative: 1.1. Clinical assessments: Standardised measures of arm function (e.g., Fugl-Meyer Assessment) at baseline, midpoint (if applicable), and post-intervention. 1.2. System-generated metrics: The ReHabGame software will record range-of-motion data, frequency of play, and task completion rates during sessions. 1.3. Observational checklists: Researchers may observe sessions to note participant posture, any difficulties using the system, and engagement level (e.g., exercise completion, verbal feedback during sessions). 2. Qualitative data collected from the web-based questionnaire. The research team will apply a structured coding framework (e.g., Braun & Clarke’s thematic analysis) to identify key themes around usability, motivation, and perceived impact. If needed, a qualitative data analysis tool (e.g., NVivo or MAXQDA) may be used to organise and manage transcripts. |
| Secondary outcome measures | The following secondary outcome measures will be used to evaluate the feasibility, acceptability, and preliminary clinical impact of the ReHabGame intervention via a questionnaire: 1. Feasibility is measured through recruitment rate, retention rate, session adherence, data completeness, and the occurrence of adverse events, using study screening logs, attendance records, and an adverse event log. These will be assessed continuously throughout the study and summarised at post-intervention (6–8 weeks). 2. Acceptability and user engagement are measured using automated gameplay metrics (e.g., frequency of use, task completion rates) collected at post-intervention (6–8 weeks) The measures will be collected at baseline, post-intervention (6–8 weeks), and 6-month follow-up, where feasible. |
| Overall study start date | 01/07/2024 |
| Completion date | 01/07/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 for each arm |
| Key inclusion criteria | 1. Adults (aged 18 years or older) diagnosed with a neurological condition, such as stroke, traumatic brain injury (TBI), or multiple sclerosis (MS), that affects upper-limb motor function. 2. To ensure sufficient functional ability to engage with the ReHabGame system, participants must meet at least one of the following objective inclusion criteria: 2.1. A Fugl-Meyer Assessment – Upper Extremity (FMA-UE) score between 20 and 50 (indicating mild-to-moderate impairment and sufficient voluntary movement) 2.2. A Box and Block Test score of ≥5 blocks per minute (demonstrating basic grasp-and-release function) 2.3. Active range of motion (AROM) of at least 10° in both shoulder and elbow flexion, or a Modified Ashworth Scale score of ≤3 at the elbow or wrist (to exclude those with severe spasticity that would hinder interaction). 3. Participants must be willing and able to commit to a 6–8 week game-based rehabilitation program (attending 1–2 sessions per week) 4. Have the capacity to provide informed consent, either independently or with support from a caregiver or legally authorised representative |
| Key exclusion criteria | 1. Medical Instability: Unstable cardiac, respiratory, orthopedic, or neurological conditions (e.g., uncontrolled seizures, severe arrhythmias) that pose a safety risk 2. Severe Motor Deficit: Complete paralysis (e.g., plegia) or extreme spasticity preventing meaningful interaction with the system 3. Contraindications to VR/Motion Tracking: Severe motion sickness, significant visual impairments, epilepsy triggered by visual stimuli, or other conditions making Kinect/VR usage unsafe 4. Concurrent Participation in Conflicting Studies: Currently enrolled in another interventional study or rehabilitation program that could confound results |
| Date of first enrolment | 01/07/2025 |
| Date of final enrolment | 01/06/2027 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
16 Watermark Way
John Tate Road
Hertford
SG13 7TZ
United Kingdom
6-7 Castle Gate
Castle Street
Hertford
SG14 1HD
United Kingdom
Sponsor information
University/education
Bishop Hall Lane
Chelmsford
CM1 1SQ
England
United Kingdom
| Phone | +44 (0)1223698234 |
|---|---|
| dannielle.green@aru.ac.uk | |
| Website | https://www.aru.ac.uk/ |
"ROR" |
https://ror.org/0009t4v78 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/11/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Anglia Ruskin University (ARU), as the Sponsor, retains ownership of all data generated by this study. The findings will be disseminated through a range of academic and public channels to maximise impact and transparency: 1. Peer-reviewed journal publications in the fields of rehabilitation science, digital health, and neurotechnology. 2. Conference presentations and abstracts at national and international events, including rehabilitation, neurophysiotherapy, and clinical innovation meetings. 3. Internal reports and briefings for institutional stakeholders and clinical collaborators. 4. Plain language summaries are shared with participants, clinical sites, and relevant charities or patient groups to ensure the accessibility of results. 5. Online publication via the university website, open-access repositories, and digital newsletters, where appropriate. |
| IPD sharing plan | This study does not plan to share individual participant data (IPD) beyond the study team at this stage. All data will be securely stored and handled in accordance with the General Data Protection Regulation (GDPR) and Anglia Ruskin University (ARU) data governance policies on a two-factor authenticated OneDrive. However, the following conditions apply for potential future sharing: 1. Anonymised datasets may be made available for secondary research purposes upon request, but only if such use is consistent with participant consent and ethical approvals. 2. Any data shared will be fully anonymised, meaning it will not contain any personal identifiers and will not allow individuals to be identified, directly or indirectly. 3. Requests for access to anonymised IPD must be submitted in writing to the Chief Investigator. They will be reviewed by the study's data access oversight group or ARU’s Research Governance team. 4. Any approved sharing of IPD will be governed by a data sharing agreement, which will define how the data may be used, stored, and cited, and ensure compliance with all legal and ethical standards. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 19/05/2025 | No | Yes |
Additional files
Editorial Notes
11/06/2025: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2025 to 01/07/2025.
2. The study participating centres Uclh Outreach: Portland Hospital, Uclh Outreach: the Wellington Hospital were removed.
